EUCTR2017-004341-24-HR进行中（未招募）1 期
Efficacy of pregabalin and duloxetine in patients with painful diabetic peripheral neuropathy (PDPN): the effect of pain on cognitive function, sleep and quality of life (BLOSSOM) - BLOSSOM
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Female and male patients aged 18-85 years.
- •2.Patients with a history of type 2 diabetes mellitus according to The American Diabetes Association
- •3.Patients with a diagnosis of painful diabetic peripheral neuropathy (PDPN) caused by type 2 diabetes
- •mellitus based on Douleur Neuropathique questionnaire (DN4 =4).
- •4.Patients whose average pain intensity in PDPN in last 24 hours (measured by VAS), evaluated on
- •baseline visit, is equal or more than 40 mm (0 mm =’no pain’ and 100 mm =’worst possible pain’).
- •5.Ability to adhere to trial protocol.
- •6.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1.Patients who took PDPN medication and/or analgesics on a day of baseline visit.
- •2.Patients with a known hypersensitivity to duloxetine, pregabalin, paracetamol or tramadol or any of
- •the inactive ingredients or have any contraindication for the use of duloxetine, pregabalin,
- •paracetamol or tramadol.
- •3.Patients with a history of inadequate pain response (pain reduced was equal or less than 30%) to:
- •3.1 pregabalin at maximum allowed treatment daily dose 600 mg,
- •3.2 duloxetine at maximum allowed treatment daily dose 120 mg,
- •3.3 venlafaxine at maximum allowed treatment daily dose 375 mg,
- •3.4 gabapentin on daily treatment dose more than 1800 mg
- •3.5 amitriptilin at maximum allowed treatment daily dose 150 mg.
- •4.Patients, who are currently treated with a daily dose that exceeds:
- •4.1 150 mg of pregabalin or
- •4.2 60 mg of duloxetine or
- •4.3 150 mg of venlafaxine or
- •4.4 600 mg of gabapentin.
- •5.Patients with an uncontrolled type 2 diabetes mellitus
- •6.The scores of less than 20 on Montreal cognitive assessment (MoCA).
- •7.Have any other type of neuropatic pain, contrasted to PDPN.
- •8.Evidence of another cause of distal polyneuropathy other than diabetic.
- •9.Have a serious (evaluated by physician) unstable cardiovascular (e.g. uncontrolled hypertension),
- •hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic
- •peripheral vascular disease, malignant disease or other medical condition that could lead to
- •hospitalisation during the course of the trial.
- •10.Have a diagnosis or history of uncontrolled glaucoma.
- •11.Known or suspected alcohol or drug abuse or addiction (excluding nicotine and caffeine).
- •12.Patients with any prior history of depression (less than one year after completing the last medical
- •treatment), mania, bipolar disorder, psychosis or schizophrenia.
- •13.Pregnancy, lactation and women of child-bearing potential without highly effective* or at least
- •acceptable** contraception (according to the Recommendations related to contraception and
- •pregnancy testing in clinical trials).
- •14.Patients with a history of epilepsy, stroke or neurodegenerative disease.
- •15.Patients taking Monoamine oxidase (MAO) inhibitors or are within one year of their withdrawal.
- •16.Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
- •17.Patients with suspected Restless leg syndrome (RLS).
- •18.Abnormal thyroid-stimulating hormone (TSH) concentrations (according to the references value of
- •the local laboratory).
- •19.Vitamin B12 and folic acid deficiency (according to the reference values of the local laboratory).
- •20.Surgical procedures planned to occur during trial (patients may be rescreened following completion
- •of and recovery from the surgical procedure).
- •21.Concomitant treatment that might influence the final therapeutic effect of the tested active
- •substances including non-medical treatments.
- •22.Patients who under the opinion of the investigator will not be compliant to the treatment or not be
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